105052 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 

photos, quotes, and findings from the 

photo elicitation data collection, 

alongside related findings from the 

NextGen descriptive studies. The 

exhibit will provide illustrative 

examples of how well-being has been 

influenced by program participation 

according to NextGen participants and 

staff. The exhibit will also include 

human-centered design activities that 

engage members of NextGen 

communities (where programs being 

evaluated for the NextGen Project were 

implemented) and researchers in 

descriptive study and photo elicitation 

findings by collecting data on their 

reflections on the exhibit. The WellBeing Storytelling Exhibit is also 

intended to improve understanding and 

future dissemination of study findings, 

and to pilot the method and product of 

a storytelling exhibit as a culturally 

responsive evaluation strategy. The data 

collection instruments for this project 

include photo elicitation submission 

forms for participants and staff, photo 

elicitation interview guides for 

participants and staff, and humancentered design activities at the photo 

exhibits. 

Respondents: Program participants 

and frontline staff enrolled in the 

NextGen Project; NextGen community 

members including community 

partners, employers, policymakers, 

funders, and NextGen participants and 

staff; and human services researchers 

and practitioners. All NextGen 

participants will be able to opt out of 

the data collection activities. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Photo elicitation submission form—Participants .............................................. 40 1 0.50 20 

Photo elicitation submission form—Staff ......................................................... 40 1 0.50 20 

Photo elicitation interview discussion guide—Participants .............................. 40 1 1.00 40 

Photo elicitation interview discussion guide—Staff ......................................... 40 1 1.00 40 

Human-centered design activities at the exhibit .............................................. 60 1 0.25 15 

Estimated total annual burden hours: ...................................................... ........................ ........................ ........................ 135 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Section 413 of the Social 

Security Act, as amended by the FY 

2017 Consolidated Appropriations Act, 

2017 (Pub. L. 115–31). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–30709 Filed 12–23–24; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Child Care; Statement of 

Organization, Functions, and 

Delegations of Authority; Correction 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice; correction. 

SUMMARY: The Administration for 

Children and Families (ACF) published 

a document in the Federal Register on 

December 4, 2024, concerning minor 

adjustments made to the organization of 

the Office of Child Care (OCC) in adding 

a Regional Operations Division. The 

document contained an incorrect code. 

FOR FURTHER INFORMATION CONTACT: 

Anne-Marie Twohie, Deputy Director, 

Office of Child Care, 330 C Street SW, 

Washington, DC 20201, (240) 935–1159. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register on December 

4, 2024, in FR Doc. 2024–28368 at 89 FR 

96255 in the second full paragraph of 

the third column, correct F to read: 

F. Regional Operations Division 

(KVAD): The Regional Operations 

Division is responsible for providing 

oversight, direction, and guidance to the 

10 OCC Regional Offices and integrates 

regional work in central office planning. 

Linda Hitt, 

Director, Office of the Executive Secretariat. 

[FR Doc. 2024–30650 Filed 12–23–24; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Center for Drug 

Evaluation and Research’s (CDER), 

Office of Surveillance and Epidemiology 

(OSE) and Office of New Drugs (OND) 

has modified their organizational 

structure. The new organizational 

structure was approved by the Secretary 

of Health and Human Services on 

November 20, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Wade, Acting Director, Division 

of Reorganizations and Delegations of 

Authority, Office of Budget, Office of 

Finance, Budget, and Acquisitions, 

Food and Drug Administration, 10903 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 105053 

New Hampshire Ave., Silver Spring, MD 

20993, 240–731–0192. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

revised to reflect the Food and Drug 

Administration’s reorganization of 

CDER’s OSE and OND. 

The purpose of this reorganization is 

to strengthen OSE and OND’s ability to 

support FDA’s mission and streamline 

its operations. 

Within OSE, the newly elevated 

Office of Regulatory Science (ORS) will 

provide scientific and technical 

leadership in pharmacovigilance 

informatics, regulatory informatics 

systems, and science operations, 

including securing access to necessary 

data sources for drug product 

surveillance operations and overseeing 

applied research studies. While the 

newly elevated Office of Regulatory 

Operations (ORO) will manage strategic 

and operational projects associated with 

drug safety, particularly with drug 

safety reviews. The Executive 

Operations Staff (EOS) will liaise with 

stakeholders through the Center and the 

FDA as well as with external groups as 

appropriate to activities within OSE, 

coordinate executive operations of 

Office leadership, and support 

organizational development activities 

for OSE staff. 

Within OND, this overall 

reorganization proposal addresses key 

priorities for the country as exhibited by 

their direct connection to multiple acts 

of Congress or declarations from the 

executive branch, including the OverThe-Counter (OTC) Monograph Reform, 

Biosimilars User Fee Act III (BsUFA III), 

Opioids Public Health Emergency 

Declaration, and the SUPPORT Act. 

Through this reorganization the FDA 

will be best organized and positions to 

address the critical workload, policy 

and oversight demands expected in the 

space of biosimilars, OTC drug 

products, rare disease drug 

development, and opioids. 

The FDA’s CDER has been 

restructured as follows: 

DCDE ORGANIZATION. The CDER’s 

OSE is headed by the Director, OSE and 

includes the following: 

Office of Surveillance and Epidemiology 

(DCDE) 

Program Management and Analysis Staff 

(DCDE3) 

Executive Operations Staff (DCDE5) 

Office of Medication Error Prevention 

and Risk Management (DCDEA) 

Division of Medication Error Prevention 

and Analysis (DCDEAA) 

Division of Risk Management (DCDEAB) 

Office of Pharmacovigilance and 

Epidemiology (DCDEB) 

Division of Epidemiology I (DCDEBA) 

Division of Epidemiology I (DCDEBB) 

Division of Pharmacovigilance I 

(DCDEBC) 

Division of Pharmacovigilance I 

(DCDEBD) 

Office of Regulatory Science (DCDEC) 

Division of Regulatory Science and 

Applied Research (DCDECA) 

Division of Pharmacovigilance 

Informatics and Operations 

Management (DCDECB) 

Office of Regulatory Operations 

(DCDED) 

Division of Regulatory Project 

Management I (DCDEDA) 

Division of Regulatory Project 

Management II (DCDEDB) 

DCDG ORGANIZATION. The CDER’s 

OND is headed by the Director, OND 

and includes the following 

organizational units: 

Office of Neuroscience (DCDGA) 

Division of Neurology I (DCDGAB) 

Division of Neurology II (DCDGAC) 

Division of Psychiatry (DCDGAD) 

Division of Pharmacology/Toxicology 

for Neuroscience (DCDGAF) 

Office of Cardiology, Hematology, 

Endocrinology, & Nephrology 

(DCDGB) 

Division of Metabolism & Endocrinology 

Products (DCDGBA) 

Division of Pulmonary, Allergy & 

Rheumatology Products (DCDGBB) 

Division of Anesthesia, Analgesia & 

Addiction Products (DCDGBC) 

Office of Immunology & Inflammation 

(DCDGC) 

Division of Gastroenterology & Urologic 

Products (DCDGCA) 

Division of Bones, Reproductive & 

Urologic Products (DCDGCB) 

Division of Dermatology & Dental 

Products (DCDGCC) 

Office of Infectious Diseases (DCDGD) 

Division of Anti-Infective Products 

(DCDGDA) 

Division of Anti-Viral Products 

(DCDGDB) 

Division of Transplant & 

Ophthalmology Products (DCDGDC) 

Office of Rare Diseases, Pediatrics, 

Urology & Reproductive Medicine 

(DCDGE) 

Division of Pediatrics and Maternal 

Health (DCDGEC) 

Division of Pharmacology/Toxicology of 

Rare Diseases, Pediatrics, Urologic 

and Reproductive Medicine 

(DCDGED) 

Division of Urology, Obstetrics, and 

Gynecology (DCDGEF) 

Division of Rare Diseases (DCDGEG) 

Division of Medical Genetics (DCDGEH) 

Office of Oncologic Diseases (DCDGF) 

Office of Therapeutic Biologics & 

Biosimilars (DCDGG) 

Division of Policy (DCDGGA) 

Division of Scientific Review (DCDGGB) 

Office of Administrative Operations 

(DCDGH) 

Administrative Analysis Staff 

(DCDGH1) 

Administrative Operations Staff 1 

(DCDGH2) 

Administrative Operations Staff 2 

(DCDGH3) 

Administrative Operations Staff 3 

(DCDGH4) 

Administrative Operations Staff 4 

(DCDGH5) 

Administrative Operations Staff 5 

(DCDGH6) 

Financial Services Staff (DCDGH7) 

Office of Nonprescription Drugs 

(DCDGI) 

Nonprescription Drugs Pharmacology 

Toxicology Staff (DCDGI1) 

Division of Nonprescription Drugs I 

(DCDGIA) 

Division of Nonprescription Drugs II 

(DCDGIB) 

Division of Nonprescription Drugs III 

(DCDGIC) 

Division of Pharmacology/Toxicology 

for Nonprescription Drugs (DCDGID) 

Office of Specialty Medicine (DCDGJ) 

Division of Ophthalmology (DCDGJA) 

Division of Imaging & Radiation 

Medicine (DCDGJB) 

Office of New Drug Policy (DCDGK) 

Division of Clinical Policy (DCDGKA) 

Division of Regulatory Policy (DCDGKB) 

Office of Regulatory Operations 

(DCDGL) 

Division of Regulatory Operation for 

Infectious Disease (DCDGLA) 

Division of Regulatory Operations for 

Oncologic Disease (DCDGLB) 

Division of Regulatory Operations for 

Nonprescription Drugs (DCDGLC) 

Division of Regulatory Operations for 

Neuroscience (DCDGLD) 

Division of Regulatory Operations for 

Cardiology, Hematology, 

Endocrinology & Nephrology 

(DCDGLE) 

Division of Regulatory Operations for 

Immunology & Inflammation 

(DCDGLF) 

Division of Regulatory Operations for 

Rare Diseases, Pediatrics, Urology & 

Reproductive Medicine (DCDGLG) 

Division of Regulatory Operations for 

Specialty Medicine (DCDGLH) 


ddrumheller on DSK120RN23PROD with NOTICES1
105054 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 

Division of Regulatory Operations for 

Pain, Anesthesia, and Addiction 

Medicine (DCDGLI) 

Office of Program Operations (DCDGM) 

Executive Operations Staff (DCDGM1) 

Business Process & Analysis Staff 

(DCDGM2) 

Learning & Talent Development Staff 

(DCDGM3) 

Program Development, Implementation 

& Management Staff (DCDGM4) 

Office of Drug Evaluation Science 

(DCDGN) 

Division of Clinical Outcome 

Assessment (DCDGNA) 

Division of Biomedical Informatics, 

Research & Biomarker Development 

(DCDGNB) 

Office of Pain, Anesthesia, and 

Addiction Medicine (DCDGO) 

Division of Anesthesia and Pain 

Medicine (DCDGOA) 

Division of Substance Use Disorder 

Medicine (DCDGOB) 

Division of Pharmacology/Toxicology 

for Pain, Anesthesia, and Addiction 

Medicine (DCDGOC) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

This reorganization is reflected in 

FDA’s Staff Manual Guide (SMG). 

Persons interested in seeing the 

complete Staff Manual Guide can find it 

on FDA’s website at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/ 

StaffManualGuides/default.htm. 

Authority: 44 U.S.C. 3101. 

Xavier Becerra, 

Secretary of Health and Human Services. 

[FR Doc. 2024–30334 Filed 12–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5353] 

Privacy Act of 1974; System of 

Records 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services. 

ACTION: Notice of a modified system of 

records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, the Department of Health 

and Human Services (HHS) is modifying 

an existing departmentwide system of 

records, ‘‘Federal Advisory Committee 

Membership Files,’’ System No. 09–90– 

0059. The modifications include, among 

other things, adding records about any 

prospective guest speakers at Federal 

advisory committee meetings who 

disclose financial interests and 

professional relationships related to the 

matter they will be speaking on, and 

changing the name of the system of 

records to ‘‘Federal Advisory 

Committee/Subgroup Member, 

Subscriber/Registrant, and Guest 

Speaker Records.’’ 

DATES: In accordance with 5 U.S.C. 

552a(e)(4) and (11), the modified system 

of records is effective December 26, 

2024. The new and revised routine uses 

will be effective January 27, 2025. 

Submit any comments by January 27, 

2025. 

ADDRESSES: The public should submit 

written comments, by mail or email, to 

Beth Kramer, HHS Privacy Act Officer, 

at 200 Independence Ave. SW, Suite 

729H, Washington, DC 20201, or 

Beth.Kramer@hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

General questions about the modified 

system of records should be submitted 

by mail, email, or telephone to Beth 

Kramer, HHS Privacy Act Officer, at 200 

Independence Ave. SW, Suite 729H, 

Washington, DC 20201, or 

Beth.Kramer@hhs.gov or 202–690–6941. 

SUPPLEMENTARY INFORMATION: This 

departmentwide system of records 

currently covers records retrieved by 

personal identifier about: (1) members 

and prospective members of HHS 

advisory committees established under 

the Federal Advisory Committee Act 

(FACA) and (2) members of the public 

who have requested to be included in 

mailing lists in order to receive 

publications or notices of information 

issued or posted by a particular HHS 

Federal advisory committee. The system 

of records notice (SORN) is being 

revised to add three additional 

categories of individuals and records, 

i.e.: (1) records about any members of 

working groups or subcommittees (i.e., 

subgroups) of an HHS Federal advisory 

committee who are not appointed as 

members of the committee, which are 

similar to the committee member 

records currently covered in the SORN, 

(2) records about individuals who 

register to attend HHS Federal advisory 

committee meetings, which are similar 

to the subscriber records currently 

covered in the SORN, and (3) records 

about prospective guest speakers at HHS 

Federal advisory committee meetings, 

which are described in section I., below; 

and to make other modifications. All 

modifications are summarized in 

section II., below. 

I. Background on Guest Speaker 

Records 

A ‘‘guest speaker’’ is an individual 

whose professional background or other 

qualifications are checked and/or who is 

screened for possible conflicts of 

interest (financial interests and 

professional relationships) related to a 

matter the guest speaker wishes to speak 

on at an HHS Federal advisory 

committee meeting, so that the agency 

can decide whether to invite the 

individual to speak and can publicly 

acknowledge the speaker’s relevant 

qualifications and interests at the start 

of the meeting, to enable the committee 

members to objectively evaluate the 

speaker’s presentation. The term ‘‘guest 

speaker’’ as used in SORN 09–90–0059 

does not include agency employees 

speaking at an HHS Federal advisory 

committee meeting in an official, 

governmental capacity and individual 

participants in the public hearing 

portion of an advisory committee 

meeting. A guest speaker is either a nonFederal government employee (nonFGE) or a special government employee 

(SGEs) acting in a non-official, nongovernmental capacity. 

Only certain HHS components, such 

as the Food and Drug Administration 

(FDA), screen guest speakers for 

potential conflicts of interest (all FDA 

advisory committees must conduct 

conflict screening of potential guest 

speakers). Such screening promotes 

transparency and openness in the 

advisory committee process and 

supports compliance with the 

requirement in 5 U.S.C. 1004(b)(3) and 

41 CFR 102–3.105(g) to prevent 

committees’ advice and 

recommendations from being influenced 

by special interests. For FDA, such 

screening also supports compliance 

with the requirement in FDA 

regulations at 21 CFR 14.60(b)(2) to 

document in meeting minutes the 

‘‘names and affiliations or interests of 

public participants.’’ 

Guest speakers who are screened for 

conflicts are not required to complete a 

Federal confidential financial disclosure 

form. The invitation extended to them 

to participate as a guest speaker in an 

HHS Federal advisory committee 

meeting may be conditioned on their 

voluntary disclosure of potential 


ddrumheller on DSK120RN23PROD with NOTICES1